4.0

credits

Average Course Rating

Acquaints students with the regulatory and ethical standards of conducting trials in accordance with FDA Code of Federal Regulations and ICH GCP Guidelines. Provides students with background and resources needed to conduct clinical trials in healthy populations. Completes a project based on a real-world vaccine trial focusing on logistical and operational components of protocol design, informed consent process, recruitment considerations, human subjects protection including adverse event assessments and reporting. Includes the responsibilities of ethical review committees, principal investigators, and sponsors; investigational product management and preparation; data collection methods; quality assurance and quality control (QA/QC). Offers contributors to the course who have experience conducting clinical trials research in various settings.